Pacemaker Clinical Trial
Official title:
Comparison of in Office Interrogation vs. Remote Measurements
The primary objective of this study is to evaluate the efficacy of the automated data
collection in the Zephyr device as compared to manual testing results for atrial and
ventricular pacing thresholds. The secondary objectives include: to compare the in-clinic
time needed to retrieve and document the automated device measurements for all tests to the
additional time needed to manually measure sensing, impedance and thresholds for the same
patient; to compare the accuracy of the automated device test results to manual testing
results; evaluate the percentage of patients who are recommended for ACapTM Confirm
utilization.
The Primary Hypotheses are:
1. The values reported from ACapTM Confirm will be within 0.125 V of the value that is
obtained manually in clinic.
2. The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value
that is obtained manually in clinic.
n/a
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